Recruiting

Dementia

Sponsor:

The University of Texas Health Science Center at San Antonio

Code:

NCT05592678

Conditions

Alzheimer's Disease (AD)

Dementia

Cognitive Decline

Mild Cognitivie Impairment (MCI)

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Not accepted

Interventions

Donepezil

Study Details

Brief summary:

The goal of this clinical trial is to demonstrate potential improvements in clinical trial methods relating to dementia and cognitive decline. The main questions it aims to answer are:

  • Can an intervention's outcome be better assessed by a latent variable ("δ") integrating cognitive performance with functional status?
  • Can latent biomarkers of δ guide the selection of an intervention that will modulate dementia severity?
  • Can a latent variable, derived from information collected remotely from caregivers, preselect subjects most likely to respond to the intervention?
  • Is the effect of the intervention in fact medicated by changes in the targeted biomarker?

In this case, the biomarker will be a latent variable derived from several proteins measured in blood (i.e., so-called "adipokines"). The intervention will be donepezil, a medication approved for the treatment of Alzheimer's Disease, but only recently associated with adipokine changes.

Participants with cognitive impairment and their caregivers will be interviewed by telephone and those newly prescribed donepezil by their provider for cognitive impairment will be recruited and enrolled. On the basis of the caregiver's report, the cognitively impaired subjects will be assigned to two groups based on a prediction of their response to donepezil. Researchers will compare those groups to see if dementia severity, as measured by δ, improves in predicted responders, and whether the change in the d-score is mediated by changes in adipokines.

Conditions

Alzheimer's Disease (AD)

Dementia

Cognitive Decline

Mild Cognitivie Impairment (MCI)

Study ID

NCT05592678

Start date

Aug 5, 2024

Status verified date

Apr, 2026

Completion date

Nov 30, 2028

Anticipated

Primary completion date

Nov 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Ambulatory outpatient volunteers with co-informants.
2. Aged 65-100 years
3. Clinical diagnosis of AD, or MCI.
4. Capacity to give informed consent.
5. GDS score (15 item) ≤ 8.
6. No significant visual or hearing impairments
7. Standardized dECog score between 1.0 and 5.0 relative to ADNI's cohort.

Exclusion Criteria:

1. A history of psychosis, including visual hallucinations;
2. History or treatment for Parkinson's, or tremor, or Rapid Eye Movement (REM) behavior disorder;
3. History of bradycardia or syncopal events;
4. Treatment for cancer in the last 5 years (excluding skin cancers);
5. Major surgery in the last year;
6. Treatment for a seizure disorder with anticonvulsants;
7. Treatment for agitation or psychosis with neuroleptics (treatment of anxiety or insomnia allowed);
8. Current treatment with donepezil or any other AChEI or exposure within the last six months
9. With a recently started Donepezil Rx (< 2 weeks), inability to stop Donepezil treatment for 14 days prior to study enrollment.
10. AChEI treatment not appropriate due to negative risk/benefit ratio based on medical Hx and symptoms during screening. Evaluated by PI and referring clinician.
11. Co-participation in another study that the PI feels would pose a safety risk or adversely affect data integrity of this study.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Predicted Responders

Group assignment determined by a response predictor algorithm derived from remotely acquired caregiver reports of cognitive performance. The donepezil administered during the study is prescribed by the subject provider as standard of care.

other: Predicted Non-Responders

Group assignment determined by a response predictor algorithm derived from remotely acquired caregiver reports of cognitive performance. The donepezil administered during the study is prescribed by the subject provider as standard of care.

Interventions

Donepezil

Donepezil is administered as a standard of care treatment by the subject's provider.

Primary outcome measure

  • dTEL change [ Time Frame: At baseline, and weeks 4, 12 and 24. ]

Central Contacts and Locations

Central contacts

Samuel Guess

210 567 8133guesss@uthscsa.edu

Floyd Jones

210 450 3158JONESFA@uthscsa.edu

Locations

Univeristy of Texas Health Science Center at San Antonio (UTHSCSA)

Recruiting

San Antonio, Texas, United States, 78229-3900

Contacts

Samuel Guess

210 567 8133guesss@uthscsa.edu

Floyd Jones

JONESFA@uthscsa.eduJONESFA@uthscsa.edu

More Information

Sponsor

The University of Texas Health Science Center at San Antonio

Last update posted

May 5, 2026

Last verified

Apr, 2026

Keywords

  • adipokines
  • cognition
  • dementia
  • functional status
  • intelligence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio on 2026-05-05.